Cuff Electrode with Soft Edges for Tissue Protection

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Solution Overview

Problem

Cuff electrodes and optrodes for implantable medical devices often cause compression injuries and tissue damage due to pressure peaks at the edges, leading to nerve blood flow impairment, demyelination, and axonal degeneration, while also experiencing issues with stray currents and virtual electrode formation.

Innovation Solution

The design features a cuff electrode/optrode with a support sheet that forms a tubular or helical structure with soft edge portions, where the mean edge thicknesses are lower than the central thickness, and the inner surface extends beyond the central outer surface, reducing pressure on the tissue and minimizing current leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If the cuff electrode uses a uniform thickness design, then the manufacturing is simple, but pressure peaks occur at the edges causing tissue damage

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidtissue damage from pressure peaks
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The cuff electrode employs variable thickness design where the edge portions have reduced thickness compared to the central portion. This local variation in geometric properties softens the edges to reduce pressure peaks on the tissue while maintaining structural integrity in the central region, directly resolving the contradiction between manufacturing simplicity and tissue protection.

Inventive Principle:
Principle #3Local quality

2Strength

If the cuff electrode has thick edges for structural support, then the mechanical strength is improved, but compression injuries and nerve damage occur

Engineering Contradiction:
Improvestructural supportVSAvoidcompression injuries
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The design distributes structural support functions to the central portion with greater thickness while reducing edge thickness to minimize compression injuries. This local differentiation allows the cuff to maintain overall structural integrity without transmitting excessive pressure to the tissue at the edges.

Inventive Principle:
Principle #3Local quality

3Ease of manufacture

If the cuff electrode uses straight edges, then the manufacturing is easier, but stray currents and virtual electrode formation increase

Engineering Contradiction:
Improveedge fabricationVSAvoidstray currents
Core Design Contradiction:
Ease of manufactureVSObject-generated harmful factors

Solution Approach 1:

Instead of using straight edges that create sharp discontinuities, the invention inverts the approach by using bevelled or rounded edges that create gradual transitions. This geometric inversion eliminates the sharp boundaries that generate virtual electrodes and stray currents, while the bevelled edges remain manufacturable with standard techniques.

Inventive Principle:
Principle #13The other way round (Inversion)

4Object-affected harmful factors

If the cuff electrode uses bevelled edges to reduce pressure, then tissue damage is reduced, but the manufacturing complexity increases

Engineering Contradiction:
Improvetissue damageVSAvoidedge geometry complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The invention modifies the geometric parameters of the edge portions by reducing thickness and applying bevels, which can be achieved through standard manufacturing processes like laser cutting or precision machining. These parameter changes effectively reduce tissue damage while maintaining manufacturing feasibility within existing technological capabilities.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS11318301B2Cuff electrode or optrode comprising soft edges and process for the production thereof
Publication Date: 2022.05.03 SYNERGIA MEDICAL
  • US11318301B2 patent drawing
  • US11318301B2 patent drawing
  • US11318301B2 patent drawing

AI summary

An implantable cuff electrode and/or optrode (40) adapted to encircle a substantially cylindrical tissue (70), is provided that includes a support sheet (43) rolled about a longitudinal axis, forming a cuff of inner diameter, Dc, and extending over a length, L a central portion, extending over a length, lc, of at least 50% of the length, L, and having a mean central thickness, tc, and wherein the central portion is flanked on either side by, a first edge portion (43e) of mean edge thickness, te1, and a second edge portion (43e) of mean edge thickness, te2, at least a first electrode contact or a first optrode exposed at an inner surface of the cuff, and remote from an outer surface forming the exterior of the cuff, Characterized in that, the mean edge thicknesses, te1, te2, of the first and second edge portions are each lower than tc.